T H E U N I V E R S I T Y O F B R I T I S H C O L U M B I A

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Department of Health Care and Epidemiology

Faculty of Medicine
Mather Building, 5804 Fairview Avenue
Vancouver, B.C. V6T 1Z3

Chemicals, Health and Pregnancy –

Thyroid Effects and Sources of Exposure

Principal InvestigatorDr. Kay Teschke PhD,Professor

School of Population and Public Health

University of British Columbia

(604) 822-2041

Co-InvestigatorDr. Scott Venners PhD, Assistant Professor,

Department of Health Sciences

Simon Fraser University

Phone: (778) 782-8494

Co-Investigator,Glenys Webster MRM PhD Candidate

Study Coordinator,School of Environmental Health

and Emergency ContactUniversity of British Columbia

(604) 827-5454 (available 24 hours a day, 7 days a week)

Consent Form, Part 2: Blood and Hair Banking Program for Future Research

  1. Introduction

In addition to the main part of the research, you are being invited to participate in a tissue banking program, which will store left-over maternal serum, cord serum, and hair for future research.

This consent form is in addition to the consent form for the main part of the study. Participation in the tissue banking program is an entirely optional part of the overall study. You may still participate in the main study if you do not wish to participate in the tissue banking program.

  1. Your participation is voluntary

Participating in this tissue banking program is entirely voluntary. If you decide to participate but change your mind at any point in the future, you are free to withdraw at any time without giving any reasons for your decision.

  1. Who is conducting the tissue banking program?

This program is being conducted by the researchers named above at the University of British Columbia, in the School of Population and Public Health and the School of Environmental Health, at Simon Fraser University in the Department of Health Sciences, and at BC Children’s & Women’s Hospital.

  1. Study Background

Exposures during fetal life may affect the development of the fetus, as well as the health and development of infants and children. To study these processes, biological samples (such as maternal serum and cord serum) must be collected during pregnancy and at delivery, and stored until the children from these pregnancies grow older.

  1. What is the purpose of the tissue banking program?

The purpose of this tissue-banking program is to provide biological samples for future research on environmental chemicals, pregnancy and child health which may be difficult or impossible to study without banked samples. For example, a future study could investigate the links between prenatal chemical exposures and child development. Evidence from hair samples may allow us to determine how animal-based foods contribute to the level of environmental chemicals stored in the body. These banked samples will allow us to ask new research questions in a timely and cost-effective manner as funding becomes available and as scientific knowledge develops over time.

  1. Who can participate in the program?

You are eligible to participate in the tissue banking program if you have agreed to take part in the UBC research study entitled “Chemicals, pregnancy and health: thyroid effects and sources of exposure”.

  1. What does the tissue banking program involve?

If you consent, a small sample of your hair will be collected at the interview, and stored.

In addition, any left-over tissue from the original samples (e.g., maternal serum, cord serum) will be stored in a freezer at Simon Fraser University. All samples will be identified only by the research code assigned in the main part of the study and will not contain any personally identifying information. (The key to this code will be held only by the study coordinator and will be held in a locked filing cabinet at UBC.)

The samples will be stored under the custodianship of Dr. Scott Venners (Simon Fraser University).Samples will not be used for commercial purposes.

If you agree to being contacted in the future, we may invite you to provide additional samples (e.g. breast milk) for future studies, or to participate in follow-up studies of your child’s development. You may indicate your willingness to be contacted for future studies at the end of this consent form.

  1. What are the possible harms and side effects of participating?

There are no known risks of participating in this program.

  1. What are the benefits of participating in this program?

You will not receive any direct benefits for your participation. However, by taking part in this program, you will help to develop scientific knowledge in an emerging area of research, which may ultimately lead to improved public health.

  1. What happens if I decide to withdraw my consent to participate?

Your participation in this research is entirely voluntary. You may withdraw from the tissue bankingprogram at any time. If you decide to participate in the program and then decide to withdraw at any time in the future, your samples will have their ID number removed and they will be discarded according to standard laboratory procedures. There will be no penalty or loss of benefits to which you are otherwise entitled, and your future medical care will not be affected. If you wish to withdraw from the tissue banking program, please contact Glenys Webster, the study coordinator, at the number listed above.

  1. What happens if something goes wrong?

Signing this consent form in no way limits your or your child’s legal rights against the sponsors of the research, investigators, or anyone else.

  1. After the program is finished

Your samples will be stored until they have been used up, until they are no longer needed for research purposes, or until you request for them to be withdrawn from the tissue bank.

  1. Possible Cost to You for Participating

There are no costs to you for participating in this program.

  1. Payment to You for Participating

You will not receive any payment for participating in this program

  1. Will my participation in this study be kept confidential?

Your confidentiality will be respected. No information that discloses your identity will be released or published without your specific consent to the disclosure. However, future research records and medical records identifying you may be inspected in the presence of the Investigator or her designate by representatives of future study sponsors, Health Canada, or the UBC Research Ethics Board for the purpose of monitoring future research. No records which identify you by name or initials will be allowed to leave the Investigators' offices.

  1. Who do I contact if I have questions about the study during my participation?

If you have any questions or desire further information about this tissue banking program, either before or during your participation, please contact the program coordinator, Glenys Webster, at 604 827-5454.

  1. Who do I contact if I have questions or concerns about my rights as a subject?

If you have any concerns about your or your child’s rights as a research subject and/or your experiences while participating in this program, contact the Research Subject Information Line in the University of British Columbia Office of Research Services at 604-822-8598

  1. Conflict of Interest

There are no known conflicts of interest on the part of the study investigators.

Subject consent to participate

  • I have read and understood this optional consent form. I have had sufficient time to consider the information provided and to ask for advice if necessary.
  • I understand that my participation in this tissue bankingprogram is entirely voluntary and that I may refuse to participate or withdraw from the program at any time without affecting my participation in the main study, and without changing in any way the quality of care that I receive.
  • I understand that all of the information collected will be kept confidential and will only be used for scientific purposes.
  • I have been told that I will receive a dated and signed copy of this consent form for my own records.
  • I understand that I am not waiving any of my legal rights by signing this consent form.
  • My signature below indicates that I consent to participate in the sections of this study checked below:

Banking of left-over mother’s serum

Banking of left-over umbilical cord serum

Banking of mother’s hair collected at the time of interview

Study personnel may contact me about providing additional samples (e.g. breast milk)

Study personnel may contact me about future research studies

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Printed Name of Subject SignatureDate

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Printed Name of Witness SignatureDate

Printed Name ofSignatureDate

Principal Investigator

Consent Form, Part 2: Chemicals, health and pregnancy – thyroid effects and sources of exposure 1 of 4

Version 7(Feb 8, 2010)